BETNESOL-N 0.01% W/W, 3500 IU/ML EYE OINTMENT 0.1/0.5%w/ %v/v Eye Ointment

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

BETAMETHASONE SODIUM PHOSPHATE NEOMYCIN SULFATE

Dostopno od:

UCB Pharma Limited

INN (mednarodno ime):

BETAMETHASONE SODIUM PHOSPHATE NEOMYCIN SULFATE

Odmerek:

0.1/0.5%w/ %v/v

Farmacevtska oblika:

Eye Ointment

Tip zastaranja:

Product subject to prescription which may not be renewed (A)

Status dovoljenje:

Withdrawn

Datum dovoljenje:

0000-00-00

Lastnosti izdelka

IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0365/046/002
Case No: 2077742
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
UCB PHARMA LIMITED
208 BATH ROAD, SLOUGH, BERKSHIRE SL1 3WE, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
BETNESOL - N 0.1% / 0.5% EYE OINTMENT
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 10/02/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/02/2010_
_CRN 2077742_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betnesol - N 0.1% / 0.5% Eye Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Betamethasone Sodium Phosphate 0.10% w/w
Neomycin Sulphate 0.50% w/w (equivalent to 3500 IU/g)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye ointment
A smooth off-white translucent ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the short-term treatment of steroid responsive inflammatory conditions of the eye when prophylactic antibiotic
treatment is also required, after excluding the presence of viral and fungal disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including the elde